IGI A-IG-0005-V1.5

GUDID 07290016855012

The Image-Guided Implantation system is an image-guided surgery system, designed to provide guidance of surgical instruments used in dental implantation procedures. The system implements the well-established advances in the fields of computer-aided surgery and image-guided surgery into the field of dental implantology. The IGI-system provides accurate guidance of the surgical instruments with regard to the patient’s anatomical structures and to the pre-surgical plan, based on the patient’s CT imaging. The system is an infra-red optics-based navigational system, which utilizes an infra-red camera sensor and light-emitting diodes (LEDs) to monitor objects in a defined space. The system comprises of the following components: computer processing unit, monitor, tracking camera and trackable appliances (designed to monitor the surgical hand-piece and patient position).

IMAGE NAVIGATION LTD

Dental stereotactic surgery system

• Primary Device ID: 07290016855012
• NIH Device Record Key: db2b2e7e-d1dc-46f7-81b6-760977c0864c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IGI
• Version Model Number: A-IG-0005-V1.5
• Catalog Number: A-IG-0005-V1.5
• Company DUNS: 532112401
• Company Name: IMAGE NAVIGATION LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97226417748
• Email: info@image-navigation.com
• Phone: +97226417748
• Email: info@image-navigation.com
• Phone: +97226417748
• Email: info@image-navigation.com
• Phone: +97226417748
• Email: info@image-navigation.com
• Phone: +97226417748
• Email: info@image-navigation.com
• Phone: +97226417748
• Email: info@image-navigation.com
• Phone: +97226417748
• Email: info@image-navigation.com
• Phone: +97226417748
• Email: info@image-navigation.com
• Phone: +97226417748
• Email: info@image-navigation.com
• Phone: +97226417748
• Email: info@image-navigation.com
• Phone: +97226417748
• Email: info@image-navigation.com
• Phone: +97226417748
• Email: info@image-navigation.com
• Phone: +97226417748
• Email: info@image-navigation.com
• Phone: +97226417748
• Email: info@image-navigation.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016855012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023424

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07290016855012]

Moist Heat or Steam Sterilization

[07290016855012]

Moist Heat or Steam Sterilization

[07290016855012]

Moist Heat or Steam Sterilization

[07290016855012]

Moist Heat or Steam Sterilization

[07290016855012]

Moist Heat or Steam Sterilization

[07290016855012]

Moist Heat or Steam Sterilization

[07290016855012]

Moist Heat or Steam Sterilization

[07290016855012]

Moist Heat or Steam Sterilization

[07290016855012]

Moist Heat or Steam Sterilization

[07290016855012]

Moist Heat or Steam Sterilization

[07290016855012]

Moist Heat or Steam Sterilization

[07290016855012]

Moist Heat or Steam Sterilization

[07290016855012]

Moist Heat or Steam Sterilization

[07290016855012]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-04
• Device Publish Date: 2020-11-26

On-Brand Devices [IGI]

• 07290016855005: The Image-Guided Implantation system is an image-guided surgery system, designed to provide guid
• 07290016855012: The Image-Guided Implantation system is an image-guided surgery system, designed to provide guid